Olympus Corporation of the Americas Recall 92728
Description: The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5
Olympus Corporation of the Americas Recall 92728 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2447-2023 |
| Event ID | 92728 |
| Event Description | The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 29590 units |
| Recall Reason | The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure. |
| Device Classification | 20230830 |
| Device Code Info | UDI-DI: 04953170355929. All lot numbers |
| Center Classification Date | 20230823 |
| Recall Initiation Date | 20230712 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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